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Completed

NCT Number: NCT02516254

Assessment of the Efficacy of Vitamin D-fortified Bread in Healthy Adults

The aim of this study is to evaluate the efficacy of daily intake of fortified bread with vitamin D on serum 25-hydroxyvitamin D level, glycemic and lipidemic status in healthy subjects compared to vitamin D supplement.

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Key information

Conditions

Healthy Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Vitamin D Deficiency

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Sixty apparently healthy subjects will be selected. Participants who are receiving vitamin D, calcium or omega-3 supplements within the last three months will be excluded. Subjects will be assigned randomly to one of the three intervention groups: 1.fortified bread+placebo,2. plain bread+vitamin D supplements,3. plain bread+placebo. Each participant will consume 50 g of bread and supplement or placebo every day for 2 months.

At the first and last visits, dietary and laboratory assessments will be performed for all subjects. Primary outcomes are improvement in vitamin D status and secondary outcome is improvement of glycemic and lipidemic markers and prevention of problems related to hypovitaminosis D.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 20 to 50 years
  • healthy subjects
  • no receiving vitamin D or omega-3 supplement in past 3 months

Exclusion criteria

  • receiving vitamin D or omega-3 supplement during the study

Treatment and study plan

fortified bread

Dietary Supplement

50 g of fortified bread + placebo daily

Other names: FB

Supplement

Dietary Supplement

vitamin D supplement+ plain bread

Other names: SP

Placebo

Dietary Supplement

plain bread+placebo

Other names: PP

Primary outcomes

  1. 25-hydroxyvitamin D (nmol/L)

    Time frame: 8 weeks

Secondary outcomes

  1. serum glucose (mg/dL)

    Time frame: 8 weeks

  2. serum triglyceride (mg/dL)

    Time frame: 8 weeks

  3. serum total cholesterol (mg/dL)

    Time frame: 8 weeks

  4. serum LDL

    Time frame: 8 weeks

  5. serum HDL (mg/dL)

    Time frame: 8 weeks

  6. serum PTH (pg/mL)

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

National Nutrition and Food Technology Institute

Other

Registry information

Official study title

Comparison of the Efficacy of Vitamin D-fortified Bread Versus Vitamin D Supplement in Healthy Adults: a Randomized Controlled Clinical Trial

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Aug 5, 2015
Registry last updated
Feb 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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